the Just facts Fall 2014 Letter from the President FACT recently announced that we are seeking additional public comments related to a new proposed standard that would recommend Clinical Programs achieve one-year survival within or above expected ranges. We deeply appreciate the quick action of several of our colleagues who have already submitted comments. Such feedback not only helps us refine requirements and guidance, but to better present our intended interpretation of the proposed standard. No decisions have been made based on comments thus far; however, the following responses to recurring comments is provided to help frame the rationale behind the proposal. There are no perfect measures of one-year survival. In a nuanced specialty like blood and marrow transplantation (BMT), no measure of outcome will be perfect. Therefore, the addition of this standard to the 6th edition is purposefully included as a recommendation (i.e., a “should” standard). Available models that measure outcomes are improving and should not be ignored. As part of an effective quality management program, Clinical Programs should be evaluating their outcomes and taking necessary steps to improve. Likewise, FACT will also approach this new standard as a learning opportunity. Throughout the effective dates of the 6th edition, we will be continuously assessing how many programs did not meet expected outcomes, what was identified by associated root cause analyses, and what impact corrective action plans had. The result will be enhanced knowledge of how outcome measures, although imperfect, may or may not improve patient care. This could benefit the entire field. Just as FACT positioned itself to help programs meet FDA regulations, we have a responsibility to our accredited organizations to do the same for outcomes reporting. Comparative data must be defined. There are some questions related to what data would be used to evaluate one-year survival. In the United States, reporting to the Stem Cell Therapeutic Outcomes Database (SCTOD), managed by the Center for International Blood & Marrow Transplant Research (CIBMTR), is required by law and the outcomes published in the CIBMTR Transplant Center Survival Report will be requested. Other regions of the world should use comparative data that includes their locale, such as the schemes run by the British Society of Blood and Marrow Transplantation (BSBMT) or the Swiss Blood Stem Cell Transplant Group (SBST). Other commenters have mentioned similar initiatives in their jurisdictions, and this information is very helpful and will be considered. (continued on page 2) In this Issue: Accreditation by the Numbers • • • • • Cellular Therapy Programs Cord Blood Banks Additional Comments Requested for Standards New Faces at the FACT Office Standards to Address Novel Cellular Therapies Active Learning Forum Launched Education Calendar Editor: Kara Wacker, MBA, RAC 209 Programs Registered 71 Banks Registered 198 Programs Accredited 52 Banks Accredited 11 Applications Pending 19 Applications Pending From the President - Evaluating Clinical Outcomes (continued) Statistically, 2.5 percent of programs in the CIBMTR report will not meet expected outcomes. This is a common concern, but already addressed in the CIBMTR model, which calculates center-specific expected ranges. Those specific ranges are what would be used for purposes of compliance with this standard. Therefore, all Clinical Programs can reasonably be expected to achieve at least expected one-year survival. Reporting burden should be minimized. Reporting based on graft type will not be required. Clinical Programs will self-report their single published one-year survival measure directly to FACT via the Compliance Application and Annual Reports. However, should one-year survival fall below expected ranges, analyses of different types of grafts, transplants, and other variables would be important when creating a corrective action plan. Disincentives to treat high-risk patients must be avoided. Ideally, schemes used around the world will all be risk-adjusted to account for high-risk patients. Even so, this is a complicated statistical model to build. In the United States, the CIBMTR has devoted an enormous amount of effort to listen to the concerns and ideas of professionals in the field and has done an excellent job of developing a process that allows adequate risk adjustment for a complex group of patients. We trust other schemes will do the same. Throughout the root cause analysis process and subsequent formulation of a corrective action plan, Clinical Programs may discover instances in which high-risk patients, or those on clinical trials, were not adequately considered. But it may uncover ways to improve outcomes for those very patients. The ultimate goal is to improve outcomes for all patients. Because accreditation will not be withdrawn due to poor outcomes under the 6th edition, transplant centers should not hesitate to consider transplants as a treatment option for patients where indicated. We commend programs for compassionately providing care to our sickest of patients. What other thoughts do you have? Whether you agree or disagree with this change, your feedback is needed. Please submit your comments by December 1st. Sincerely, Helen Heslop, MD Prepare for the 6th Edition Cellular Therapy Standards FACT and JACIE are finalizing the 6th edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and its accompanying accreditation manual for publication on March 1, 2015. Accredited organizations will be expected to comply with the new edition by June 1, 2015. FACT has worked closely with organizations whose current accreditation expires around the time of publication. To be inspected under the 5th edition Standards, Compliance Applications must be submitted no later than February 28, 2015 and the on-site inspection must occur no later than May 31, 2015. The FACT Cellular Therapy Inspection & Accreditation Workshops in 2015 will include a featured session on changes made to the 6th edition, which will be supplemented by webinars. We encourage organizations to take advantage of these upcoming events. Facilities may also wish to receive tips for how to manage the transition period by viewing the recording of the Transitioning to New Standards Virtual Roundtable, originally presented in May 2012. Fall 2014 | 2 Additional Comments Requested for 6th Edition Cellular Therapy Standards FACT and JACIE are finalizing the sixth edition of the Hematopoietic Cellular Therapy Standards. Based on public comments and strategic initiatives, an additional standard is proposed to recommend that Clinical Programs achieve one-year survival within expected ranges based on published data. Comments on the following proposed standard will be accepted until December 1, 2014: “The Clinical Program should achieve one-year survival outcome within or above the expected range when compared to national or international outcome data. If expected one-year survival outcome is not met, the Clinical Program shall submit a corrective action plan.” The FACT-JACIE Standards already require internal outcome analyses. With the introduction of published comparative national and international data, Clinical Programs have additional resources to evaluate their one-year survival rates and improve upon them when they fall below expected ranges. Emphasis on benchmarking against national and international data is expected to receive more scrutiny in the development of future transplant quality review across the healthcare enterprise. Because improving one-year survival when expected ranges are not met requires a complicated and lengthy process of root cause analysis and performance improvement, Clinical Programs need to begin studying their outcome data and taking the appropriate steps. Note that this standard is written with “should,” signifying that it is a recommendation. If a Clinical Program does not meet expected outcomes, accreditation will not be withheld but the program will be required to submit a corrective action plan for achieving expected one-year survival. The Standard is planned for publication on March 1, 2015 with the full 6th edition and will become effective on June 1, 2015. The proposed standard, guidance, and instructions for submitting comments are described in the official Request for Public Review and Comment: One-Year Survival for Allogeneic Transplant Requirements. Walking the Walk – FACT Conducts Audits of its Own Processes FACT has an inspection audit system used to ensure that our inspection process is uniformly applied to all organizations. Similar to the purpose of audits in cellular therapy, our audit process is one tool we use to identify how we are doing as an organization and how we can continually improve the FACT inspection and accreditation process. Auditors are volunteers from FACT-accredited organizations who have experience in quality management. During an audit, the auditor reviews our inspection processes during an actual on-site inspection. To select inspections to audit, organizations are randomly chosen in advance and agree to participate in the inspection audit. Inspectors are also notified prior to the inspection. Examples of processes that are within the scope of the audit include notifications sent to inspection teams and inspection day activities. Results of the inspection audit are reviewed by the Quality Management committee and process improvement actions are identified and implemented. The auditor does not make decisions about or participate in the actual inspection of an organization, or make recommendations about outcomes. Auditors simply observe the process to determine if there are any areas for improvement. Such assessments and resulting improvements will ensure our inspection and accreditation process is effective and enjoyable for our applicants and inspectors. 3 | Fall 2014 New Faces at the FACT Office A testament to the interest, participation, and contributions of the cellular therapy field is the level of service accredited organizations and other stakeholders expect from FACT. To continue to provide excellent support, the staff at the FACT international headquarters has grown in the past few months and we are pleased to introduce you to the new voices you have heard and faces you will meet. FACT’s new Quality Manager, Heather Conway, CQA(ASQ), has direct experience working at the intersection of blood and marrow transplant and quality management. In her previous role at the Biologics Production Facility at the University of Nebraska Medical Center, she knows firsthand the commitment accredited organizations devote to regulatory compliance and quality management. Based on this prior experience and her two major responsibilities at FACT, performance improvement and education, she has some advice to give. “Keep an audit schedule and follow it,” she says. “Follow up on corrective actions as a result of audits and be sure to include the people that actually do the work.” Erin Tschudin, the new Education and Training Coordinator, is a professional educator with experience in needs assessments, teaching, and application of theory to practice. Her role at FACT has been to expand our educational offerings by tuning into the needs illustrated by workshop evaluations, common citations, frequently asked questions, and new requirements. She says the best way to keep up with new requirements is to keep in touch with FACT. “There are many resources for applicants and inspectors, with more planned in the near future. People can subscribe to the FACT newsletter and attend workshops and webinars. Inspectors can read the new Inspector Bulletin.” She goes on to list the many ways FACT responds to concerns and questions, “It is important for applicants and inspectors to ask questions. We have a number of ways to do this, including the Active Learning Forum on LinkedIn and the Ask FACT and ASK-A-PEER buttons on our website.” Andra Moehring, MHA, is FACT’s new Standards Development Specialist. As a former executive project management specialist for a complex health care system, she is familiar with logistical planning, meeting facilitation, strategic planning, and document creation – all important pieces of the FACT Standards development process. Immediately upon her arrival at FACT, she began reviewing feedback regarding the Cellular Therapy, Cord Blood, and Common Standards. “There are public comment periods during the Standards development process, which is a great time to share feedback or concerns about specific standards. We also take feedback at any time and refer them to the Standards Committee charged with drafting subsequent editions,” she says.“Getting involved with FACT and sitting on one of our committees is another great opportunity to share your knowledge and experiences.” The newest member of the team is Alisa Forsythe, FACT’s Information Technology (IT) Business Analyst. Ali has extensive experience working with existing IT applications and refining them to become powerful, yet user-friendly, tools. “The best way to learn is by doing, so I am learning about FACTWeb by actually using the system in an end user capacity.” That, she says, has made her eager to hear any feedback about FACTWeb from her peers, applicant organizations, and inspectors. “My goal is to focus on the usability of FACTWeb and use a thorough and holistic approach to identify robust solutions that will not only address the initial concern but also prevent any subsequent issues.” The insightful contributions made thus far by our new colleagues increase our confidence in FACT’s ability to continue providing the support we know is so important to our stakeholders. Fall 2014 | 4 Congratulations to our new inspectors! FACT applauds and thanks the following individuals who have completed the inspector training program and are now serving actively as inspectors: Racquel Innis-Shelton, MD, The University of Alabama Adult The Pre-Inspection Role of the FACT Accreditation Coordinator and Pediatric Bone Marrow Transplantation and Cell Therapy Inspection evaluations consistently say it – the Accreditation Program Coordinators at the FACT office are awesome. So much so, that Stephen Medlin, DO, University of Cincinnati George L. Strike Bone Marrow Transplant Center Charles Branson, MS, Biologics Production Facility, Nebraska Medicine, The Nebraska Medical Center the coordinators have become trusted team members within the inspection and accreditation process. The FACT Accreditation Coordinators offer a lot of advice that organizations won’t get elsewhere. After receiving preinspection documentation, they look through the information Ronit Slotky, PhD, New York Presbyterian Hospital/Weill Cornell for key evidence of inspection readiness, including submission Medical Center Bone Marrow and Hematopoietic Stem Cell of: Transplantation Program • Required pre-inspection documents (but not adequacy), Bangon (Day) Longsomboon, MA, The Cell Manufacturing Program Laboratory at the University of Miami • Current medical licenses and board certifications, • A clear and complete QM Plan and SOP for SOPs, • Required informed consent elements, Shanlong Jiang, BS, MS, New York Presbyterian Hospital/ • Complete and appropriate label content, and Columbia University Medical Center - Blood and Marrow • Appropriate steps/number of observations in validation plans. Transplant Program Dr Susana G Gomez, The Anthony Nolan Cord Blood Bank Mr. Alexander Platz, MD, DKMS Lifeline Cord Blood Bank Carlos Ramos, MD, Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital Kris Michael Mahadeo, MD, MPH, Montefiore Medical Center The coordinators also perform a cursory review for other obvious corrections that need to be made as they confirm the presence of each required pre-inspection document, but compliance with standards is not guaranteed. Subsequent submissions with corrections will be reviewed by the inspector. This initial review is a value added service, and we encourage applicant organizations and inspectors to take advantage of the insights the FACT Accreditation Coordinators have to offer. Bone Marrow and Stem Cell Transplantation Program Rabi Hanna, MD, Cleveland Clinic Foundation, Cleveland Clinic Blood and Marrow Transplant Program Dr. Yvette Tanhehco, MD, PhD, MS, New York Presbyterian Become an Inspector! Hospital/Columbia University Medical Center - Blood and Organizations whose personnel serve as FACT inspectors Marrow Transplant Program typically have better inspection results due to increased George Chen, MD, Roswell Park Cancer Institute Corporation Rodica Ciubotariu, MD, PhD, National Cord Blood Program understanding of FACT requirements and lessons learned from other accredited organizations. We encourage you and your colleagues to apply to become inspectors. Jennifer L Barton, RN, BSN, Wake Forest University Baptist Medical Center Veronica Jude, MD, Texas Transplant Institute 5 | Fall 2014 FACT Standards to Support Advancement of Novel Cellular Therapies In keeping with its objective of fostering continued development of cellular therapy, FACT is expanding its peer-driven standards development process to other cellular therapies. FACT published its draft first edition of the Common Standards for Cellular Therapies in May 2014 for public review and comment. These Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. The Standards require the establishment of a quality management program and are intended to promote quality medical and laboratory practice in a broad range of cellular therapies. As the requirements have become more defined and wellknown, FACT has received many questions from interested parties about how the Common Standards will in fact be implemented. The purpose of this article is to widely share answers to frequently asked questions. What is the scope of the Common Standards versus the Cellular Therapy and Cord Blood Standards? The Common Standards are just that – common. In other words, they apply to any kind of cellular therapy and will be included in all sets of FACT Standards. When used alone, the Common Standards will apply to any cellular therapy for which there is no specialized set of FACT Standards. This includes many investigational products used for indications other than blood cancers and diseases and products collected from sources other than marrow, peripheral blood, or cord blood. To more clearly describe the scope of each set of FACT Standards, significant thought was put into the nomenclature for each. In March 2015, the names of each set will likely be: • FACT Common Standards for Cellular Therapies • FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration • NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration If my organization uses both investigational products and standard-of-care HPC products, will I have to use two sets of Standards and have two inspections? The simple answer is no. Because all sets of Standards will include the common requirements, most organizations should only have to refer to one set of Standards and demonstrate compliance with a single on-site inspection. Standards that apply only to HPCs will be specified as such within the Standards document. The following are examples to illustrate what this means to organizations: Products Manufactured or Used Only HPC Products HPC Products and MSCs collected from marrow HPC Products and MSCs collected from adipose tissue Only MSCs collected from marrow Only MSCs collected from adipose tissue Applicable Set of Standards FACT-JACIE Hematopoietic Cell Therapy Standards FACT-JACIE Hematopoietic Cell Therapy Standards FACT-JACIE Hematopoietic Cell Therapy Standards FACT Common Standards FACT Common Standards During on-site inspections, the number of checklists and inspectors required depends on individual circumstances. To provide effective and thorough inspection services, FACT uses an algorithm to determine when there is enough variety in the scope of work, leadership, and facilities to warrant additional checklists and inspectors. In most cases, single facilities require one checklist and one inspector. However, extremely complex facilities, or organizations with activities in more than one location, often require additional resources. FACT will continue to take this approach when the Common Standards are published. What is the timeline for implementation? The Common Standards are expected to be published at the beginning of March 2015. Because the requirements in this set of standards will also be included in the sixth edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards, it makes sense to publish both documents at the same time. The update of the NetCord-FACT Cord Blood Standards to the sixth edition will begin soon, and incorporation of the Common Standards will occur during this process. (continued on page 7) Fall 2014 | 6 Will the Common Standards encompass the GMPs? The Common Standards will not include all GMPs. The Standards focus on requirements that are common to all cellular therapy products and their purpose is to help organizations set up standardized, systematic processes across their program rather than by product. In the United States, GMPs refer to a manufacturing facility that manufactures a product in compliance with FDA GMP requirements. GMPs apply to different products in different ways, and facilities cannot be GMP-approved for general product manufacturing. The FDA reviewed the Common Standards during the public comment period and recognized that it is not possible to harmonize common requirements with all applicable GMP requirements because the applicable regulations depend on a variety of factors, including the product, indication for use, and stage of product development cycle. However, as with all sets of FACT Standards, organizations are required to comply with applicable laws and regulations. GMPs for “351” products (i.e., products regulated solely under section 351 of the Public Health Service (PHS) Act) can be found in 21 CFR parts 210, 211, and 610. How could the Common Standards improve our processes? A major focus of the Common Standards is to outline how to establish and maintain a Quality Management (QM) program and demonstrate compliance with applicable laws and regulations (including many GMPs), institutional policies and procedures, and other FACT requirements. QM forms the underlying basis of FACT Standards and creates systems that set clinical units and processing laboratories up for success on all other critical points in the Standards that address important aspects beyond the technical and scientific processes. Documentation, control, and formal assessments of processes are often difficult for organizations to establish, and the Standards provide much needed direction. Is the intent of the Common Standards to only apply to non-profit or academic institutions? The Common Standards can be applied to any type of entity, including academia, industry, non-profit, and private. The Standards are organized in a manner that allows flexibility based on individual organizations’ business models. Some organizations may be responsible for a cellular therapy from donor management all the way through administration. Others may only perform the manufacturing (such as industry), while others only administer the product (such as clinics). No matter how comprehensive or limited an organization’s role is, there are always basic quality-related requirements that apply. This includes documenting chain of custody, storage conditions (whether temporary or long-term), personnel qualifications, and more. If we have an FDA-approved Investigational New Drug (IND) application, or other approval in relevant countries, how would the Common Standards benefit us? Investigators play an important role in the IND process, and clinical outcomes are reviewed by the FDA. Therefore, successful approval of therapies under IND oversight depends on clinical centers’ knowledge of regulatory requirements and ability to comply with them. Examples of direct clinical responsibilities in the IND process include reporting of adverse events, documenting and analyzing clinical outcomes, enrolling eligible candidates, administering the products as directed by the IND requirements, etc. Deciphering the applicable regulations and setting up processes to comply with them can be difficult. The Common Standards provide direction on meeting these requirements. Facilities manufacturing products benefit from the systematic improvements made to their processes. They become more efficient because they can apply the same general procedures to multiple types of products, with only processing techniques differing among products. Outside of specific IND requirements, cell therapy research depends largely on the competence and knowledge of the organizations conducting the studies. Successful translation of cellular therapy to clinics will be a result of the performance of the entire field, including those that are new to cellular therapy and have little experience. It is in everyone’s best interest that the abilities of investigators in translational research are at a level of quality that will help realize the potential of cell therapy and earn the trust of the public. This will continue for decades to come, evident by the ongoing research in hematopoietic cellular therapy. 7 | Fall 2014 ASBMT Clinical Case Forum Becomes Heavily Used Resource for Clinicians After the launch of the ASBMT Clinical Case Forum in late February, ASBMT has made tremendous progress with members using the site and posting cases. Participants are collaborating on cases and realizing positive clinical impacts for their patients. For example, see the interaction between Drs. Bill Wood and Mark Litzow on the case titled, “67 year old male with atypical CML vs MDS/MPN considering alloHCT.” The ASBMT is pleased to announce the newest area of expertise to support case collaboration in the ASBMT Clinical Case Forum. The Pharmacy Group, which consists of leaders in the field from top hospitals, will bring a new voice to the clinical collaboration among BMT specialists and keep the forum up to date on recent trends and dosages in pharmacology. Several pharmacy cases have already been posted. The ASBMT is thrilled to bring the forum to a larger audience and continue building on its success. ASBMT members have complimentary access to the Forum as a benefit of joining the society. Members can choose how to use the forum: simply review or comment on interesting BMT cases, post cases for fast feedback, or network with BMT colleagues. Log in at asbmt.medting.com. Contact [email protected] with any questions or concerns. FDA Publishes Draft Guidance Regarding Same Surgical Procedure Exception The United States Food and Drug Administration (FDA) published a draft guidance outlining its current thinking on the scope of the same surgical procedure exception set forth in 21 CFR 1271.15(b). This guidance, presented in question and answer format, when finalized will provide the FDA’s current interpretation of this regulation and includes examples based on inquiries received by the Agency since the final rule, “Human Cells, Tissues, and Cellular and Tissue Based Products; Establishment Registration and Listing” (Establishment Registration and Listing final rule) was published on January 19, 2001 (66 FR 5447). The guidance addresses the following questions: • When does the exception apply? • What is autologous use? • What types of procedures are considered the same surgical procedures? • Are there any types of procedures consisting of more than a single operation that are considered same surgical procedure? • Can an establishment that processes an autologous HCT/P after removal and prior to implantation still qualify for the exception? Comments on this draft guidance must be submitted by December 22, 2014 to be considered during preparation of the final version. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Fall 2014 | 8 Submit Your Abstract for the ISCT Annual Meeting Be a part of the conversation. Attend the World Stem Cell Summit. The ISCT Annual Meeting, co-chaired by Jacques Galipeau, MD, The World Stem Cell Summit, produced by the Genetics Policy FRCP(C); Paul Eldridge, PhD; and Hans Klingemann, MD, PhD, will Institute (GPI), is the largest interdisciplinary, networking take place from May 27 to 30, 2015 in Las Vegas, Nevada. This meeting of stem cell science and regenerative medicine international meeting will be an opportunity for dynamic and stakeholders, uniting the diverse regenerative medicine exciting interactions. community. With the overarching purpose of fostering Abstracts will be accepted until December 11, 2014. The abstract categories illustrate the well-rounded and cutting-edge nature of the ISCT Annual Meeting and include: • Cardiovascular Repair and Regeneration • Basic Biology of Non-Hematopoietic Stem Cells • Non-Hematopoietic Stem Cells Towards Clinics • Hematopoietic Stem Cells • Cell and Gene Therapy or Cellular Gene Transfer • Regenerative Medicine and Tissue Engineering • Immunotherapy & Dendritic Cells biomedical research, funding and investments targeting cures, the Summit is the single conference charting the future of this burgeoning field. Scheduled for December 3-5, in San Antonio, the program provides the research, industry, economic and societal context for understanding how all of the pieces of the stem cell puzzle fit together. The Summit is a three-day showcase of innovation, insight and inspiration. For more information please visit the World Stem Cell Summit website. • Quality & Operations • Translational Process Development • Nervous System Repair • Legal and Ethical New Publication for FACT Inspectors to Provide Helpful Information We are pleased to announce that inspectors will now receive regular communication from FACT specific to their role in the inspection and accreditation process. The Inspector Bulletin, a short monthly email, will augment general announcements and discussions distributed to all of our stakeholders. The bulletin will share commendable inspector practices, updates on inspection requirements, and suggestions. We expect this to become a useful way to maintain knowledge of the FACT inspection process. If you have any helpful tips or noteworthy information for future bulletins, please email FACT’s Education and Training Coordinator, Erin Tschudin, at [email protected]. Active Learning Forum Expands Educational Reach of FACT Webinars The launch of the FACT Active Learning Forum provides members an additional resource for implementing the theories presented during FACT webinars by sharing their knowledge, experiences, and critical thinking with their peers. Through this forum, professionals are able to exchange ideas and learn from one another. Although the discussions are based on FACT webinar topics, forum members do not have to attend those sessions to join the discussion. Participation of all members is encouraged to expand the educational outreach of the cellular therapy community. To join the FACT Active Learning Forum: 1. Log into http://www.linkedin.com or create a LinkedIn profile. 2. In the search box at the top of the screen, enter “FACT Active Learning Forum.” Click Groups on the left side of the screen. 3. Click on FACT Active Learning Forum and then click Join. 9 | Fall 2014 the JUST F all facts 2014 Keep Current with FACT Education that Supports Trends in Cellular Therapy The bar is rising and the scope is expanding. Transplant programs are poised to take quality to soaring levels. Clinical specialties are discovering how cells can provide hope to their patients. Cord blood banks are blazing trails of discovery. As FACT requirements keep up with the pace, rise to the occasion with us. Knowledge is power. Register at www.factwebsite.org. Fall 2014 | 10
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